FDA Warns of Painkiller Risk During Pregnancy

By Robert Preidt

HealthDay reporter

FRIDAY, October 16, 2020 (HealthDay News) – If you’re pregnant and think it’s safe to use nonsteroidal anti-inflammatory drugs (NSAIDs) for your aches and pains, think again.

The United States Food and Drug Administration warned Thursday that taking these widely used pain relievers – which include Advil, Motrin, Aleve and Celebrex – at 20 weeks or more of a pregnancy could increase the risk of complications.

Specifically, taking these drugs can cause rare but serious kidney problems in the unborn baby that can lead to low levels of amniotic fluid, increasing the risk of pregnancy complications.

After about 20 weeks of pregnancy, the fetal kidneys begin to produce most of the amniotic fluid, so kidney problems can lead to low levels of this protective fluid. According to the FDA, low levels of amniotic fluid usually go away if a pregnant woman stops taking an NSAID.

The agency said it had ordered labeling of NSAIDs to warn women and their health care providers of the risk.

NSAIDs are prescription and over-the-counter (OTC) medications that include ibuprofen, naproxen, diclofenac, and celecoxib, which are taken to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules do not apply to low dose aspirin use.

“It is important for women to understand the benefits and risks of medications they can take during pregnancy,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement. agency press release.

An ob-gyn noted that over-the-counter NSAIDs may pose the greatest danger to pregnant women.

“Many patients regularly use ibuprofen for headaches and menstrual cramps,” said Dr. Jennifer Wu, of Lenox Hill Hospital in New York. “It is very important that these patients realize that ibuprofen and other NSAIDs pose a unique danger to pregnant patients.

“The majority of patients are given these over-the-counter drugs and can even use them at the prescription level,” Wu added. “While many prescription drugs are subject to pharmacist monitoring and a warning label Over the counter drugs lack all of this. Patients also often assume that over the counter drugs are necessarily safe. “


The FDA warning follows a review of the medical literature and cases reported to the agency of low levels of amniotic fluid or kidney problems in unborn babies associated with the use of NSAIDs during pregnancy .

For prescription NSAIDs, the new FDA warning recommends limiting use between around 20 weeks and 30 weeks of pregnancy. A warning to avoid taking NSAIDs after around 30 weeks of pregnancy was already included in the prescribing information due to a risk of heart problems in unborn babies.

If a health care provider believes NSAIDs are needed between around 20 and 30 weeks of pregnancy, use should be limited to the lowest possible dose and for the shortest possible duration, the FDA said.

Manufacturers of over-the-counter NSAIDs for adults will also make similar updates to their labeling, according to the agency.

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